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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00004932




Registration number
NCT00004932
Ethics application status
Date submitted
7/03/2000
Date registered
27/01/2003
Date last updated
21/02/2014

Titles & IDs
Public title
STI571 in Treating Patients With Recurrent Leukemia
Scientific title
A Phase I Study of STI571 in Ph+ Leukemia
Secondary ID [1] 0 0
COG-P9973
Secondary ID [2] 0 0
P9973
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - imatinib mesylate

Experimental: 260 mg/m2 imatinib mesylate (ST571) -

Experimental: 340 mg/m2 imatinib mesylate (ST571) -

Experimental: 440 mg/m2 imatinib mesylate (ST571) -

Experimental: 570 mg/m2 imatinib mesylate (ST571) -


Treatment: Drugs: imatinib mesylate


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival - To estimate the maximum tolerated dose (MTD) of STI571 administered orally once daily without interruption to children with recurrent Ph+ leukemia.
Timepoint [1] 0 0
Length of study
Secondary outcome [1] 0 0
Dose-limiting toxicities - To determine the dose-limiting toxicities (DLT) of STI571 given on this schedule.
Timepoint [1] 0 0
Length of study
Secondary outcome [2] 0 0
Characterize the pharmacokinetic behavior - To characterize the pharmacokinetic behavior of STI571 in children with recurrent Ph+ leukemia.
Timepoint [2] 0 0
Length of study
Secondary outcome [3] 0 0
Define the anti-leukemic activity of STI571 - To preliminarily define the anti-leukemic activity of STI571 within the confines of a Phase I study.
Timepoint [3] 0 0
Length of study

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Recurrent Philadelphia (Ph) chromosome-positive leukemia

- Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR

- Chronic myelogenous leukemia with resistance to interferon alfa with any of the
following:

- WBC at least 20,000/mm^3 after at least 3 months of interferon therapy

- At least 100% increase in WBC to at least 20,000/mm^3 confirmed over 2 weeks
while receiving interferon alfa

- At least 66% Ph chromosome-positive cells after 1 year of interferon therapy

- At least 30% increase in number of Ph chromosome-positive cells after an
interferon-induced response while continuing interferon therapy

PATIENT CHARACTERISTICS:

Age:

- Under 22

Performance status:

- Karnofsky 50-100% if over 10 years of age OR

- Lansky 50-100% if 10 years of age and under

Life expectancy:

- At least 8 weeks

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGPT less than 3 times normal

- Albumin greater than 2 g/dL

Renal:

- Creatinine no greater than 1.5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host
disease

- No seizure disorder if on anticonvulsants

- No uncontrolled infection

- No CNS toxicity greater than grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- At least 1 week since prior biologic therapy and recovered

- At least 3 months since prior stem cell transplantation (SCT)

- At least 1 week since prior growth factors

- At least 1 week since prior interferon alfa

Chemotherapy:

- Recovered from prior chemotherapy

- At least 6 weeks since prior busulfan and nitrosoureas

- At least 2 weeks since prior homoharringtonine

- At least 1 week since low-dose cytarabine

- At least 2 weeks since prior moderate-dose cytarabine

- At least 4 weeks since prior high-dose cytarabine

- At least 3 weeks since all other prior cytotoxic chemotherapies

- No prior hydroxyurea

Endocrine therapy:

- Must be on a stable dose of steroids if received prior allogeneic SCT

Radiotherapy:

- Recovered from prior radiotherapy

- At least 2 weeks since prior local palliative radiotherapy (small port)

- At least 6 months since prior craniospinal radiotherapy

- At least 6 months since prior radiotherapy to 50% or more of the pelvis

- At least 6 weeks since other prior substantial bone marrow radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational agents

- No concurrent anticonvulsants
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
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3052 - Parkville
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6001 - Perth
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an
effective treatment for leukemia.

PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients
who have recurrent leukemia.
Trial website
https://clinicaltrials.gov/show/NCT00004932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Champagne, MD
Address 0 0
Hopital Sainte Justine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications